Evaluating a Single-session Mental Health Intervention for UK University Students

NCT05093816 | Unknown

• 1 other identifier: 21-212
• Study Type: interventional
• Target: 700
• Locations: 0 countries
• Sites: N/A

Brief Summary

The investigators are evaluating if an online single-session intervention, the Common Elements Toolbox (COMET) can improve mental health and wellbeing among UK university students.

Conditions

Depression; Anxiety; Happiness

Outcome Measures

Primary Outcomes (6)

• Patient Health Questionnaire-9 (PHQ-9)

  Measure of depressive symptoms. Scores range from 0-27, with higher scores indicating greater levels of depression.

  Change from baseline to four weeks post-intervention

• Generalized Anxiety Disorder 7-item Checklist (GAD-7)

  Measure of anxiety symptoms. Scores range from 0-21, with higher scores indicating greater levels of anxiety.

  Change from baseline to four weeks post-intervention

• Short Warwick-Edinburgh Mental Well-being Scale (SWEMWBS).

  Measure of wellbeing. Scores range from 7-35, with higher scores indicating greater well-being.

  Change from baseline to four weeks post-intervention

• Positive and Negative Affect Schedule

  A measure of positive affect and negative affect. Scores on the positive affect subscale range from 10-50, with higher scores indicating greater positive affect. The negative affect subscale also ranges from 10-50, with greater scores indicating greater levels of negative affect.

  Change from baseline to four weeks post-intervention

• Acceptability of Intervention Measure (AIM)

  Measure of acceptability. Scores range from 4-20, with higher scores indicating greater acceptability.

  Post-intervention (immediately after participants complete the intervention)

• Intervention Appropriateness Measure

  Measure of appropriateness. Scores range from 4-20, with higher scores indicating greater appropriateness.

  Post-intervention (immediately after participants complete the intervention)

Study Arms (2)

Common Elements Tooplbox

EXPERIMENTAL

Behavioral: Common Elements Toolbox

Wait-list control

NO INTERVENTION

Interventions

Common Elements Toolbox BEHAVIORAL

The Common Elements Toolbox (COMET) is an online single-session intervention. It is entirely self-guided and lasts about 60 minutes. Participants complete a series of reading and writing exercises focused on four modules: cognitive restructuring, behavioral activation, gratitude, and self-compassion. The intervention is entirely unguided and completed in a single sitting.

Common Elements Tooplbox

Eligibility Criteria

• Age: 18 Years+
• Sex: all
• Healthy Volunteers: Yes
• Age Groups: Adult (18-64), Older Adult (65+)

You may qualify if:

• At least 18 years old

Sponsors & Collaborators

• University of Pennsylvania: lead
• University of Bath: collaborator

MeSH Terms

Conditions

Depression; Anxiety Disorders

Condition Hierarchy (Ancestors)

Behavioral Symptoms; Behavior; Mental Disorders

Study Design

• Study Type: interventional
• Phase: not applicable
• Allocation: RANDOMIZED
• Masking: NONE
• Purpose: TREATMENT
• Intervention Model: PARALLEL
• Sponsor Type: OTHER
• Responsible Party: SPONSOR

Study Record Dates

• First Submitted: October 1, 2021
• First Posted: October 26, 2021
• Study Start: October 20, 2021
• Primary Completion: October 1, 2022
• Study Completion: September 1, 2023
• Last Updated: October 28, 2021

Record last verified: 2021-10